A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant

Running, not enrolling · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to see if the quality of T cells used to create ide-cel (bb2121) affects how ide-cel prevents cancer from coming back in people with relapsed or refractory multiple myeloma (MM), and who have had a hematopoietic cell transplant.

Key facts

Study ID

NCT05393804

Run by

Memorial Sloan Kettering Cancer Center

People needed

24

Starts

2022-05-20

Expected to finish

2027-05-01

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohort 1:
• Patient with myeloma who has received at least four prior lines of treatment having been exposed to an IMID, PI, and a CD38 monoclonal antibody and had measurable disease prior to salvage high dose melphalan autoHCT done within the prior 2 - 6 months. (Salvage melphalan/AutoHCT can count as the 4th line of treatment).
• Measurable disease is defined by any of the following:
• M-spike ≥ 0.5mg/dL
• Urine m-spike ≥ 200mg/dL/24 hours
• Involved Serum Free light chain ≥ 10mg/dL
• Measurable plasmacytoma on imaging (≥ 1 lesion that has a single diameter ≥ 2 cm).
• Bone marrow plasma cells ≥ 30% as determined by CD138 immunohistochemistry staining
• Cohort 2:
• Patients with pathologically confirmed MM who have received at least 4 prior lines of treatment having been exposed to an IMID, PI, and a CD38 monoclonal antibody and have undergone an allo HCT for RRMM at any time in their history and have at least minimal residual disease by flow or NGS in the bone marrow at least 3 months after allo HCT.
• Prior to Leukapheresis:
• Greater than age 18.
• Karnofsky performance ≥ 70.
• Recovered to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding Grade 2 neuropathy
• Not receive any systemic anti-myeloma therapy for 14 days prior to leukapheresis. Therapeutic doses of corticosteroids (defined as greater than 10 mg/day prednisone or equivalent) are permitted until within 72 hours prior to Leukapheresis.
• Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 without filgrastim use in the prior 14 days.
• Hemoglobin ≥ 8 g/dL (without red blood cell transfusion in the previous 7 days)
• Creatinine Clearance (CrCl) ≥ 45 mL/min, measured or estimated by Cockcroft-Gault equation.
• Corrected serum calcium ≤ 13.5 mg/dL
• Oxygen saturation ≥ 92% on room air
• Hepatic Function:
• Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN
• Serum total bilirubin Serum total bilirubin ≤ 2 x ULN. Patients who have been diagnosed with Gilbert's disease are permitted to exceed the defined bilirubin value of 2 x ULN 2 x ULN. Patients who have been diagnosed with Gilbert's disease are permitted to exceed the defined bilirubin value of 2 x ULN
• International ratio (INR) or partial thromboplastin time (PTT) ≤ 1.5 x ULN
• Cardiac Function: left ventricular ejection fraction ≥ 45% by echocardiogram (ECHO) or multigated acquisition scan (MUGA).

You may not qualify if…

• Receiving any of the following less than 14 days prior to enrollment:
• Plasmapheresis
• Major surgery (as defined by the investigator)
• Radiation therapy other than local therapy for MM-associated bone lesions
• Prior organ transplant requiring systemic immunosuppressive therapy
• History of ≥ Grade 2 hemorrhage within 30 days of enrollment
• Patient requiring ongoing treatment with chronic, therapeutic dosing of anticoagulants (e.g., Warfarin, low molecular weight heparin, Factor Xa inhibitors) can be enrolled with approval of the PI.
• History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
• Having concurrent Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
• History of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or hemodynamically significant ventricular arrhythmia within the previous 6 months prior to enrollment
• Active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible. Patients with a history of acute or chronic GVHD are potentially eligible if on minimal immunosuppressants as defined previously.
• Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B or C, or acute hepatitis A. If any history of exposure to hepatitis B or C, then DNA PCR should be negative. If hepatitis B core Ab positive with negative DNA PCR, patients should be on prophylaxis while on study.
• Prior malignancies except resected basal cell carcinoma or treated carcinoma in situ. Cancer treated with curative intent less than 5 years prior to enrollment will not be allowed unless approved by the PI. Cancer treated with curative intent greater than 5 years prior to enrollment is allowed.
• Female patients who are breastfeeding or who intend to become pregnant during participation in the study.
• Known allergy or hypersensitivity to any of the study medications, their analogues, or excipients in the various formulations of any agent.
• Serious medical of psychiatric illness likely to interfere with participation on this clinical study
• Uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
• Unwilling or unable to provide informed consent
• Unable or unwilling to return to the center for treatment and follow up
• No systemic anti-myeloma therapy is allowed within 7 days prior to leukapheresis. Steroids are allowed, but should be tapered off by 72 hours prior to leukapheresis.
• Steroids are allowed between leukapheresis and LD chemotherapy, but should be tapered off by 72 hours prior to lymphodepletion.

Where it is running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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